Once final approval comes through, the liquid anticoagulant will be made at Lupin’s plant in Somerset, New Jersey, the company said.
Mumbai: Lupin has received tentative approval from the US Food and Drug Administration for its new drug application for apixaban oral suspension 1.25 mg/mL, the drugmaker said in a stock exchange filing on Monday.
The application was filed through the 505(b)(2) pathway, according to the company. The product is a liquid version of apixaban, the active ingredient in Bristol Myers Squibb’s blood thinner Eliquis.
Apixaban is an oral anticoagulant used to prevent and treat blood clots and to lower the risk of stroke in people with nonvalvular atrial fibrillation. Lupin said the suspension gives adult patients on anticoagulation therapy another way to take the drug, including those who have trouble swallowing tablets.
Chief Executive Vinita Gupta said the approval reflected the company’s focus on differentiated medicines that meet real patient needs, and that the suspension widens the ways in which the therapy can be given. She described it as part of Lupin’s effort to build a differentiated portfolio.
Manufacturing will take place at Lupin’s Somerset facility in New Jersey after final clearance, the company said. It did not give a timeline for final approval or for a US launch.
The approval comes as Lupin reports stronger numbers. Its consolidated profit after tax rose 16.08 per cent to Rs 1,415 crore in the first quarter of FY27, while net sales climbed 33.32 per cent to Rs 8,217.23 crore compared with the same quarter a year earlier, according to Business Standard.
Source: Business Standard and The Free Press Journal, 28 September 2026
